401 KAR 5:320. Wastewater Laboratory Certification Program

Link to law: http://www.lrc.ky.gov/kar/401/005/320.htm
Published: 2015

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      401 KAR 5:320. Wastewater Laboratory Certification Program.

 

      RELATES TO: KRS 224.01-010, 224.10-100, 224.10-670,

224.70-100, 224.70-110, 40 C.F.R. 136, 33 U.S.C. 1342

      STATUTORY AUTHORITY: KRS 224.10-670

      NECESSITY, FUNCTION, AND CONFORMITY: KRS 224.10-670 authorizes the cabinet

to promulgate administrative regulations establishing standards for the

operation of laboratories, fees for certification and competency evaluation of

those laboratories, issuance of certificates of competency, and a certification

program for laboratories that submit environmental data as it relates to

analyses and laboratory tests for activities subject to 33 U.S.C. 1342.

This administrative regulation establishes the wastewater laboratory certification

program, standards for the certification of wastewater laboratories, and fees

for certification and evaluation of wastewater laboratories.

 

      Section 1. Definitions. (1) "Analysis

category" means one (1) of the following analyte groups for which an

analysis can be performed by a wastewater laboratory:

      (a) Inorganic general chemistry;

      (b) Inorganic metals;

      (c) Organic chemistry volatiles;

      (d) Organic chemistry semi-volatiles;

      (e) Organic chemistry pesticides, herbicides,

or PCBs;

      (f) Organic chemistry dioxins;

      (g) Microbiology;

      (h) Whole effluent toxicity; and

      (i) Field analysis.

      (2) "Certified" means that the

cabinet has determined that the wastewater laboratory meets the regulatory

performance criteria and the standard of quality established in this

administrative regulation and has issued a certification.

      (3) "Equivalency of certification"

means certification of a wastewater laboratory by an entity, other than the

cabinet, whose requirements for certification are determined by the cabinet to

meet the requirements of this administrative regulation.

      (4) "Field analysis" means a

measuring of the following:

      (a) Dissolved oxygen;

      (b) Residual chlorine;

      (c) pH;

      (d) Temperature;

      (e) Conductivity; and

      (f) Turbidity.

      (5) "Field-only wastewater

laboratory" means a wastewater laboratory that performs a measurement for

only the parameters identified as field analysis, regardless of whether the

measurement takes place outdoors, in an on-site room used as a laboratory, or

in an off-site laboratory.

      (6) "General wastewater laboratory"

means a wastewater laboratory that performs an analysis for at least one (1) analysis

category other than field analysis, regardless of whether the general

wastewater laboratory also performs a field analysis measurement.

      (7) "Interim certification" means

a certification approved by the cabinet if it determines through documentation

review that the wastewater laboratory meets the requirements of Section 10 of

this administrative regulation. Interim certification is applicable to a

method-analyte pairing until the cabinet has completed an on-site audit for

that method-analyte pairing.

      (8) "Primary analyst or technician"

means an analyst or technician who performs a specific method-analyte pairing

analysis more often than any other analyst or technician at that wastewater

laboratory.

      (9) "Wastewater laboratory"

means a laboratory that performs an analysis, measurement, or laboratory test

for an activity subject to 33 U.S.C. 1342.

 

      Section 2. Effective Date for this

Administrative Regulation. The effective date for this administrative

regulation shall be:

      (1) January 1, 2014, for a general

wastewater laboratory; and

      (2) January 1, 2015, for a field-only

wastewater laboratory.

 

      Section 3. Requirement for Acceptance of

Environmental Data. (1) In accordance with KRS 224.10-670(2) and the schedule

established in subsection (2) of this section, environmental data from analyses

and laboratory tests submitted to the cabinet for activities subject to 33 U.S.C.

1342 shall be performed:

      (a) By a certified wastewater laboratory;

and

      (b) In compliance with:

      1. An analytical method in 40 C.F.R. Part

136 or as established in the applicable permit;

      2. This administrative regulation; and

      3. The provisions of the Commonwealth of

Kentucky Wastewater Laboratory Certification Manual.

      (2) The requirements established in

subsection (1) of this section shall begin on:

      (a) January 1, 2015, for a general

wastewater laboratory; and

      (b) January 1, 2016, for a field-only

wastewater laboratory.

 

      Section 4. Certification Requirements. The

requirements established in this section shall apply to a wastewater laboratory

seeking certification.

      (1) Application for certification shall

be made on the Kentucky Wastewater Laboratory Certification Program,

Application for Kentucky Laboratory Certification, KWLCP Form App, and shall

include all information required by that form, and shall be submitted with the

applicable fee as established in Section 8 of this administrative regulation as

follows:

      (a) If in paper form, to:

      Kentucky Division of Water

      Attn: Laboratory Certification

      200 Fair Oaks Lane, 4th Floor

      Frankfort, Kentucky 40601; or

      (b) If in electronic form, via the

cabinet’s Web site:

      www.water.ky.gov.

      (2) The wastewater laboratory shall apply

for certification for each analysis category and for each method-analyte

pairing for which the wastewater laboratory intends to perform an analysis.

 

      Section 5. Term of Certification Periods

for a General Wastewater Laboratory. (1) The initial certification period for a

general wastewater laboratory shall be from January 1, 2014, until December 31,

2015, and subsequent certification periods shall be consecutive two (2) year

periods, beginning January 1, 2016.

      (2) If, beginning January 1, 2016, a general

wastewater laboratory applies for initial certification of the wastewater

laboratory or for certification for a new method-analyte pairing, the initial

certification period shall be the two (2) year period as established in subsection

(1) of this section, based upon the date of application receipt by the cabinet.

 

      Section 6. Term of Certification Periods

for a Field-Only Wastewater Laboratory. (1) The initial certification period

for a field-only wastewater laboratory shall be from January 1, 2015, until December

31, 2016, and subsequent certification periods shall be consecutive two (2)

year periods, beginning January 1, 2017.

      (2) If, beginning January 1, 2017, a

field-only wastewater laboratory applies for initial certification of the

wastewater laboratory or for certification for a new method-analyte pairing,

the initial certification period shall be the two (2) year period as

established in subsection (1) of this section, based upon the date of

application receipt by the cabinet.

 

      Section 7. Due Date for Certification

Renewal Applications. (1) If an application, the Kentucky Wastewater Laboratory

Certification Program, Application for Kentucky Laboratory Certification, KWLCP

Form App, for certification renewal is received by the cabinet by November 15

of the odd-numbered year of the current certification period for a general

wastewater laboratory, or November 15 of the even-numbered year of the current

certification period for a field-only wastewater laboratory, the application shall

be considered timely submitted, and the wastewater laboratory’s certification

shall continue in effect until the cabinet acts upon the application, unless

the certification is otherwise revoked.

      (2) If an application, the Kentucky

Wastewater Laboratory Certification Program, Application for Kentucky Laboratory

Certification, KWLCP Form App, for certification renewal is received by the cabinet

after November 15 but on or before December 15 of the odd-numbered year of the

current certification period for a general wastewater laboratory, or after

November 15 but on or before December 15 of the even-numbered year of the

current certification period for a field-only wastewater laboratory, the application

shall not be considered timely submitted, and shall be subject to the surcharge

established in Section 8(4) of this administrative regulation. The wastewater

laboratory’s certification shall continue in effect until the cabinet acts upon

the application, unless the certification is otherwise revoked.

      (3) If an application, the Kentucky

Wastewater Laboratory Certification Program, Application for Kentucky

Laboratory Certification, KWLCP Form App, for certification renewal is received

by the cabinet after December 15 of the odd-numbered year of the current certification

period for a general wastewater laboratory, or after December 15 of the

even-numbered year of the current certification period for a field-only

wastewater laboratory, the application shall not be considered timely submitted,

and shall be subject to the surcharge established in Section 8(5) of this administrative

regulation. The wastewater laboratory’s certification shall expire after December

31 of that odd-numbered year for a general wastewater laboratory, or after

December 31 of that even-numbered year for a field-only wastewater laboratory, and

shall not be valid until the cabinet acts upon the renewal application.

 

      Section 8. Annual Certification Fees. (1)

The annual certification fees for wastewater laboratory certification shall be established

in Table 1 of subsection (2) of this section and shall include:

      (a) A nonrefundable administrative fee;

and

      (b) A fee for each applicable analysis

category.

      (2) If a follow-up audit is performed to verify

the correction of a deficiency identified by an audit pursuant to Section 10 of

this administrative regulation, an additional audit fee, established in Table 1,

shall be assessed.

 

Table 1: Wastewater Laboratory Certification

Fee



Fee Category





Annual Fee







Administrative Fee





$1,000







Analysis Category Fee





 







 Inorganic general chemistry





$500







 Inorganic metals





$500







 Organic chemistry volatiles





$500







 Organic chemistry semi-volatiles





$500







 Organic chemistry pesticides, herbicides, PCBs





$500







 Organic chemistry dioxins





$750







 Microbiology





$500







 Whole effluent toxicity





$1,000







 Field analysis only





$250







 Follow-up Audit Fee





$500





      (3) The applicable certification fee

shall be due by November 15 of each year. In odd-numbered years of the certification

period for a general wastewater laboratory, or in even-numbered years of the

certification period for a field-only wastewater laboratory, the applicable certification

fee shall be submitted concurrent with the renewal certification application,

the Kentucky Wastewater Laboratory Certification Program, Application for

Kentucky Laboratory Certification, KWLCP Form App.

      (4)(a) If a fee is received by the cabinet

after November 15 but on or before December 15, the wastewater laboratory shall

incur a surcharge of fifteen (15) percent of the applicable certification fee

(administrative fee plus analysis category fee).

      (b) Payment of this surcharge shall be due

thirty (30) days after notice is provided by the cabinet.

      (5) If a fee is received by the cabinet after

December 15, the wastewater laboratory shall incur a surcharge of twenty-five

(25) percent of the applicable certification fee.

      (a) The wastewater laboratory’s

certification shall expire after December 31 of that year and shall not be valid

until the applicable certification fee and the surcharge are received by the

cabinet.

      (b) Payment of this fee and surcharge

shall not reinstate certification for failure to timely submit an application

for certification renewal pursuant to the expiration established in Section 7(3)

of this administrative regulation.

      (6) A wastewater laboratory seeking or

obtaining equivalency of certification shall receive a twenty (20) percent reduction

of the certification fee.

      (7) An in-state laboratory that is also

certified for drinking water analysis, as established in 401 KAR 8:040, shall

receive a twenty (20) percent reduction of the certification fee.

      (8) A wastewater laboratory that provides

only field analysis shall be exempt from the annual administrative fee

established in Table 1 of subsection (2) of this section.

      (9) A wastewater laboratory operated by a

facility that has been issued a Kentucky Pollutant Discharge Elimination System

permit and that is providing only field analysis for only its own facility

shall be exempt from all fees established in this administrative regulation.

      (10) A wastewater laboratory operated by

a municipality that provides analysis for only its own facility shall receive

the following reduction to the administrative fee established in Table 1 of

subsection (2) of this section, based on its maximum permitted flow value:

      (a) Less than or equal to 0.10 million

gallons per day (MGD), a 100 percent reduction (no administrative fee);

      (b) Less than or equal to 0.50 MGD but

greater than 0.10 MGD, a seventy-five (75) percent reduction;

      (c) Less than or equal to one and zero

tenths (1.0) MGD but greater than zero and five tenths (0.5) MGD, a fifty (50)

percent reduction;

      (d) Less than or equal to two and zero

tenths (2.0) MGD but greater than one and zero tenths (1.0) MGD, a twenty-five

(25) percent reduction; and

      (e) Greater than two and zero tenths (2.0)

MGD, a ten (10) percent reduction.

      (11) If more than one (1) reduction

pursuant to subsections (6) through (10) of this section applies, only the

greatest reduction shall be taken.

 

      Section 9. Interim Certification. (1) If

a wastewater laboratory demonstrates that the following requirements are met

for a method-analyte pairing, the cabinet shall approve interim certification

for that method-analyte pairing:

      (a) All information required by the Kentucky

Wastewater Laboratory Certification Program, Application for Kentucky

Laboratory Certification, KWLCP Form App, shall be submitted to the cabinet;

      (b) The appropriate fee shall be submitted

to the cabinet;

      (c) A method, including instrumentation,

established in 40 C.F.R. Part 136 or the applicable permit shall be used; and

      (d) A proficiency test study sample shall

be analyzed by the primary analyst or technician within the last year and the

results shall be within the acceptance limits specified by a proficiency test

study provider approved by the American Association for Laboratory Accreditation.

      (2) A wastewater laboratory with interim

certification may analyze samples for that method-analyte pairing for

compliance purposes.

 

      Section 10. Audits. (1) A certified

wastewater laboratory shall allow a cabinet auditor to conduct, and shall

participate in, an on-site audit during normal business hours.

      (2) Wastewater laboratory certification

records and supporting documentation shall be retained for five (5) years or

until the next on-site audit, whichever is longer.

      (3) If the cabinet identifies a

deficiency, the certified laboratory shall correct or otherwise address the

deficiency within thirty (30) days of receipt of notice of the deficiency.

      (4)(a) If an on-site audit of a

wastewater laboratory located outside of Kentucky is conducted by the cabinet,

the wastewater laboratory shall bear the reasonable cost of the audit.

      (b) Payment shall be due thirty (30) days

after notice of this cost is provided by the cabinet.

 

      Section 11. Full Certification Requirements.

(1) If, after an on-site audit and review of submitted information, all

requirements of this administrative regulation for a method-analyte pairing have

been met, the cabinet shall approve full certification for that method-analyte

pairing.

      (2) To maintain full certification for

the method-analyte pairing, the wastewater laboratory shall:

      (a) Maintain compliance with the

requirements of this administrative regulation, based upon the cabinet’s review

of requested documentation, on-site audit inspection, or both;

      (b) Analyze a proficiency test study

sample at least annually by the primary analyst or technician and the results

shall be within the acceptance limits specified by a proficiency test study

provider approved by the American Association for Laboratory Accreditation. If

the wastewater laboratory fails a proficiency test study, the wastewater

laboratory shall, within ninety (90) days after receiving notice of the failed

proficiency test study, analyze a second proficiency test study with the results

within the acceptance limits specified by an approved proficiency test study

provider;

      (c) Notify the cabinet within thirty (30)

calendar days of a change in the personnel, equipment, analytical method, or

laboratory location identified in its application, Kentucky Wastewater Laboratory

Certification Program, Application for Kentucky Laboratory Certification, KWLCP

Form App;

      (d) Submit documentation or data required

by this administrative regulation; and

      (e) Submit to the cabinet all fees by the

deadlines established in this administrative regulation.

 

      Section 12. Provisional Certification.

(1) The cabinet shall, when becoming aware of a failure of a wastewater

laboratory to comply with one (1) or more of the requirements established in Section

11(2) of this administrative regulation, provide written notice to the wastewater

laboratory of the deficiency and of the cabinet’s intent to change the

certification status to provisional certification.

      (2) If the deficiency relates to a

specific method-analyte pairing, the cabinet may change the status of the wastewater

laboratory’s certification to provisional certification. If the status is

changed to provisional certification, this changed status shall be for only the

analyte that failed to meet the requirements of Section 11(2) of this

administrative regulation, unless the cabinet had certified a group of related analytes

based on a limited number of analytes in the group.

      (3) The wastewater laboratory shall submit

to the cabinet a written corrective action plan to address this deficiency within

thirty (30) days of receipt of the notice of intent from the cabinet,

specifying the immediate and long-term corrective actions that shall be taken.

      (4) The wastewater laboratory shall

correct this deficiency as soon as reasonably possible. If the deficiency is

not corrected within thirty (30) days of receipt of the notice of intent, the

cabinet shall change the certification status to provisional certification, and

shall provide written notice to the wastewater laboratory of this action.

      (5) A wastewater laboratory with

provisional certification may continue to analyze a sample for compliance

purposes, but shall notify its client of the wastewater laboratory’s

provisional certification status prior to conducting an analysis for that

client and shall provide that information in writing to the client.

      (6) A wastewater laboratory with

provisional certification shall correct the deficiency as soon as is reasonably

possible, but within three (3) months of written notification from the cabinet

of the change to provisional certification status.

      (7) The cabinet shall restore the

wastewater laboratory’s provisional certification status to full certification

upon making a determination that the deficiency resulting in the provisional

certification status has been corrected and shall provide written notice to the

wastewater laboratory of this action.

 

      Section 13. Certification Revocation. (1)

The cabinet may immediately revoke a wastewater laboratory’s certification for any

of the following reasons:

      (a) Failure to use an analytical method

established in 40 C.F.R. Part 136 or in the applicable permit;

      (b) Reporting proficiency test study data

from another laboratory as its own data;

      (c) Engaging in falsification of data or another

deceptive practice;

      (d) Endangering public health or the

environment through an operation associated with the wastewater laboratory;

      (e) Refusal to allow or participate in an

on-site audit conducted by the cabinet; or

      (f) Persistent failure to report accurate

compliance data to the cabinet.

      (2) If the cabinet revokes a wastewater

laboratory’s certification pursuant to subsection (1) of this section, the

cabinet shall immediately notify the wastewater laboratory of this action and provide

written notice to the wastewater laboratory of this action.

      (3) If a wastewater laboratory has not

corrected the deficiency resulting in the provisional certification status

within three (3) months of written notification from the cabinet of the change to

provisional certification, the cabinet shall provide written notice to the

wastewater laboratory of the cabinet’s intent to revoke the wastewater laboratory’s

certification for any method-analyte pairing involved in the deficiency.

      (4) The wastewater laboratory may request,

in writing, a redetermination of the cabinet’s intent to revoke certification

pursuant to subsection (3) of this section.

      (a) If a redetermination is requested,

the request shall be made within thirty (30) days of receipt of the notice of

intent to revoke.

      (b)1. This request shall be submitted to

the cabinet and shall explain the basis for the redetermination request and, if

appropriate, include a written corrective action plan to address the deficiency

identified in the cabinet’s notice of intent to revoke.

      2. The request shall be signed by a

responsible official of the wastewater laboratory.

      (5) The cabinet, having received a request

for redetermination pursuant to subsection (4) of this section, shall make a final

determination whether or not to continue provisional certification, approve

certification, or revoke certification, and shall provide written notice to the

wastewater laboratory of this action.

      (6) If, within thirty (30) days of

receipt of the notice of intent to revoke pursuant to subsection (3) of this

section, the wastewater laboratory does not request a redetermination, the

cabinet shall revoke the wastewater laboratory’s certification and provide

written notification to the wastewater laboratory of this action.

 

      Section 14. Cabinet to Develop Templates.

(1) The cabinet shall develop templates to assist wastewater laboratories in

preparing a quality assurance plan (QAP) and standard operating procedures

(SOPs) applicable for field analysis measurements.

      (2) The templates developed by the cabinet

shall address all applicable requirements for a QAP and common device SOPs, but

will require the inclusion of site-specific information to be provided by the

wastewater laboratory.

      (3) The cabinet shall provide public

notice and at least a thirty (30) day opportunity for public review and comment

on the proposed templates before finalizing these templates.

      (4) These templates may be used by a

field-only wastewater laboratory or for the field analysis portion by a general

wastewater laboratory. A wastewater laboratory is not required to use these

templates, and may independently develop its own QAP and SOPs.

      (5) The cabinet shall make the final

templates available on its Web site.

 

      Section 15. Incorporation by Reference.

(1) The following material is incorporated by reference:

      (a) "Commonwealth of Kentucky

Wastewater Laboratory Certification Manual", June 2013;

      (b) "Kentucky Wastewater Laboratory

Certification Program, Application for Kentucky Laboratory Certification",

KWLCP Form App, March 2013;

      (c) "Short-term Methods for

Estimating the Chronic Toxicity of Effluents and Receiving Waters to Freshwater

Organisms", Fourth Edition, U.S.EPA-821-R-02-013, October 2002; and

      (d) "Methods for Measuring the Acute

Toxicity of Effluents and Receiving Waters to Freshwater and Marine Organisms",

Fifth Edition U.S. EPA-821-R-02-012, October 2002.

      (2) This material may be inspected,

copied, or obtained, subject to applicable copyright law, at the Division of

Water, 200 Fair Oaks Lane, Frankfort, Kentucky 40601, Monday through Friday, 8

a.m. to 4:30 p.m. This material may also be obtained through the Division of

Water’s Web site at http://water.ky.gov. (27 Ky.R. 2603; Am. 3122; 3239; eff.

6-8-2001; 35 Ky.R. 2337; 2768; 36 Ky.R. 25; eff. 7-31-2009; T.Am. 4-4-2011; 39

Ky.R. 2094; 40 Ky.R. 33; 282; eff. 9-5-2013.)